February 7, 2019
Selecting a pharmaceutical consultant to help your organization with GMP, quality and compliance concerns can be a daunting task for any Quality executive. This is especially true for new or smaller companies that do not have existing relationships with consulting firms or solo consultants. The sheer volume of options in 2019 can make your head […]
April 5, 2018
As someone with many years of experience working in and around FDA-regulated manufacturing operations, a recent LinkedIn post (March 2018) entitled “Why QUALITY Needs to STOP Working on COMPLIANCE” has really rankled me. Unfortunately, this is not the first time this topic has been discussed. There are frequent speakers these days berating “compliance” in favor […]
January 30, 2018
On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory guidance for agency practice by substantially reducing the importance and significance of regulatory Guidance Documents for not only life sciences companies, but all industry segments. Although ironically the policy position was itself not effectuated by […]
December 8, 2017
On Thursday, December 7, Deputy Assistant US Attorney General Ethan P. Davis, US Department of Justice, Consumer Protection Branch, gave a speech at the Food and Drug Law Institute Enforcement Litigation and Compliance Conference in Washington, DC. In this speech, Deputy Assistant US Attorney General Davis outlined what may be the first tangible, specific public […]
July 25, 2017
Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a company’s characterization of what can best be considered a sham product as a medical device. See, https://www.linkedin.com/feed/update/urn:li:activity:6277978180909305856 Now, Popular Science has, in an article today, misrepresented the science, safety and […]
December 4, 2016
The election of Donald Trump as President-Elect of the United States was, and continues to be, a watershed moment in the 200+ year American experiment. The public, the business community, and government are all currently adjusting to a new, unanticipated reality. A veritable frenzy of journalistic speculation is attempting to analyze the messaging of the past, […]
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